High-Quality Engineering Solutions: Senior QA Engineer Wanted

2 days ago

Galway, Galway, Ireland beBeeSenior Full time €60,000 - €80,000
Senior Quality Assurance Engineer Opportunity

We're seeking an experienced Senior Quality Assurance Engineer to join our Receiving Inspection team in a dynamic and innovative environment.

This onsite role offers the chance to work at the forefront of innovation, supporting the development and validation of inspection processes, fixtures, and quality systems aligned with regulatory standards.

  • Lead the evaluation and implementation of inspection methods and sampling plans for high-volume and complex components.
  • Collaborate cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes.
  • Design, develop, and qualify custom inspection fixtures and measurement equipment.
  • Conduct Gage R&R studies and measurement system analyses to ensure repeatability and accuracy.
  • Develop and validate test methods in compliance with industry standards and regulatory requirements.
  • Investigate and resolve Out-of-Spec (OOS) events and drive root cause analysis and CAPA activities.
  • Support the training and supervision of lab personnel in inspection techniques and quality standards.
Required Skills and Qualifications:
  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • 5+ years of quality engineering experience within the medical device, biotech, or pharmaceutical sectors.
  • Strong experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R).
  • Proficient in CAD software (e.g., SolidWorks) and statistical analysis tools (e.g., Minitab).
  • Working knowledge of GD&T, mechanical drawings, and regulatory frameworks including ISO 13485 & FDA 21 CFR Part 820.
Benefits:

This role is ideal for someone with a proactive mindset, strong problem-solving skills, and a passion for improving human health through high-quality engineering solutions.

How to Apply:

For more details on this opportunity, feel free to contact us. We value your interest in this position and appreciate your understanding regarding our application process.

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